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Bupropion hydrochloride

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Bupropion Hydrochloride Extended-Release Tablets, USP (SR)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING


Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric DisordersPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use

: Use in Smoking Cessation Treatment ®#

####

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN#was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

#WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation TreatmentPRECAUTIONS: Information for Patients

BUPROPION HYDROCHLORIDE DESCRIPTION


1318
Bupropion hydrochloride


CLINICAL PHARMACOLOGY


Pharmacodynamics:
Pharmacokinetics:

Absorption:
max
Distribution:

Metabolism:
tert

PRECAUTIONS: Drug Interactions




Elimination:
14
Population Subgroups:

Hepatic:


maxmax½maxmaxmaxmaxWARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION
Renal:
maxPRECAUTIONS: Renal Impairment
Left Ventricular Dysfunction:

Age:
PRECAUTIONS: Geriatric Use
Gender:

Smokers:
maxmax

CLINICAL TRIALS






BUPROPION HYDROCHLORIDE INDICATIONS AND USAGE




CLINICAL PHARMACOLOGY



CLINICAL PHARMACOLOGY

BUPROPION HYDROCHLORIDE CONTRAINDICATIONS




#







WARNINGS

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders:





Table 1
Age Range
Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated

Increases Compared to Placebo
<18
14 additional cases
18 to 24
5 additional cases
Decreases Compared to Placebo
25 to 64
1 fewer case
≥65
6 fewer cases


All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.







Families and caregivers of patients being treated with antidepressants formajor depressive disorder or other indications, both psychiatric and nonpsychiatric,should be alerted about the need to monitor patients for the emergence of agitation,irritability, unusual changes in behavior, and the other symptoms described above, as wellas the emergence of suicidality, and to report such symptoms immediately to health careproviders. Such monitoring should include daily observation by families and caregivers.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment:


#(see , ). These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. BOXED WARNING ADVERSE REACTIONS



#Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN

#was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

#

Screening Patients for Bipolar Disorder:


Bupropion-Containing Products


®#®#

Seizures:


Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with bupropion. Bupropion should be discontinued and not restarted in patients who experience a seizure while on treatment.
  • Dose: At doses of bupropion up to a dose of 300 mg/day, the incidence of seizure is approximately 0.1% (1/1,000) and increases to approximately 0.4% (4/1,000) at the maximum recommended dose of 400 mg/day.
Data for the immediate-release formulation of bupropion revealed a seizure incidenceof approximately 0.4% (i.e., 13 of 3,200 patients followed prospectively) in patientstreated at doses in a range of 300 to 450 mg/day. The 450 mg/day upper limit of thisdose range is close to the currently recommended maximum dose of 400 mg/day forbupropionhydrochloride extended-release tablets (SR). This seizure incidence (0.4%) may exceed that of othermarketed antidepressants and bupropion hydrochloride extended-release tablets (SR) up to 300 mg/day by asmuch as 4-fold. This relative risk is only an approximate estimate because no directcomparative studies have been conducted.
Additional data accumulated for the immediate-release formulation of bupropion
suggested that the estimated seizure incidence increases almost tenfold between 450 and600 mg/day, which is twice the usual adult dose and one and one-half the maximumrecommended daily dose (400 mg) of bupropion hydrochloride extended-release tablets (SR). Thisdisproportionate increase in seizure incidence with dose incrementation calls forcaution in dosing.

Data for bupropion hydrochloride extended-release tablets (SR) revealed a seizure incidence of approximately0.1% (i.e., 3 of 3,100 patients followed prospectively) in patients treated at doses in arange of 100 to 300 mg/day. It is not possible to know if the lower seizure incidenceobserved in this study involving the sustained-release formulation of bupropion resulted from the different formulation or the lower dose used. However, as notedabove, the immediate-release and sustained-release formulations are bioequivalent withregard to both rate and extent of absorption during steady state (the most pertinentcondition to estimating seizure incidence), since most observed seizures occur understeady-state conditions.
  • Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.
  • Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.
  • Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.
Retrospective analysis of Recommendations for Reducing the Risk of Seizure: clinical experience gained during the development of bupropion suggests that the risk ofseizure may be minimized if
  • the total daily dose of bupropion hydrochloride extended-release tablets (SR) does not exceed 400 mg,
  • the daily dose is administered twice daily, and
  • the rate of incrementation of dose is gradual.
  • No single dose should exceed 200 mg to avoid high peak concentrations of bupropion and/or its metabolites.
Bupropion should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with other agents (e.g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.

Hepatic Impairment:


Bupropion should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced frequency and/or dose is required, as peak bupropion, as well as AUC, levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 100 mg every day or 150 mg every other day in these patients (see , , and ). CLINICAL PHARMACOLOGY PRECAUTIONS DOSAGE AND ADMINISTRATION

Potential for Hepatotoxicity:


PRECAUTIONS

General

Agitation and Insomnia:


Table 2. Incidence of Agitation, Anxiety, and Insomnia in Placebo-Controlled Trials
Adverse Event Term
Bupropion 300 mg/day (n = 376)


Bupropion 400 mg/day (n = 114)


Placebo (n = 385)

Agitation Anxiety Insomnia

3% 5% 11%


9% 6% 16%


2% 3% 6%




Psychosis, Confusion, and Other Neuropsychiatric Phenomena:


Activation of Psychosis and/or Mania:


Altered Appetite and Weight:

In placebo-controlled studies, patients experienced weight gain or weight loss as shown in Table 3.

Table 3. Incidence of Weight Gain and Weight Loss in Placebo-Controlled Trials
Weight Change
Bupropion 300 mg/day (n = 339)


Bupropion 400 mg/day (n = 112)


Placebo  (n = 347)

Gained >5 lbs Lost >5 lbs
3% 14%

2% 19%

4% 6%

Allergic Reactions:




Cardiovascular Effects:




®###

Hepatic Impairment:




CLINICAL PHARMACOLOGYWARNINGSDOSAGE AND ADMINISTRATION

Renal Impairment:


max

Information for Patients






Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment:

###

Bupropion-Containing Products: ®#®#













Laboratory Tests


Drug Interactions




max






Drugs Metabolized By Cytochrome P450IID6 (CYP2D6):
max1/2



MAO Inhibitors: CONTRAINDICATIONS

Levodopa and Amantadine:

Drugs That Lower Seizure Threshold: WARNINGS

Nicotine Transdermal System: PRECAUTIONS: Cardiovascular Effects

Alcohol: CONTRAINDICATIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility






Pregnancy


Teratogenic Effects: 22

2

Labor and Delivery


Nursing Mothers


Pediatric Use


BOX WARNINGWARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders

Geriatric Use




CLINICAL PHARMACOLOGY

PRECAUTIONS: Renal ImpairmentDOSAGE AND ADMINISTRATION

BUPROPION HYDROCHLORIDE ADVERSE REACTIONS


WARNINGSPRECAUTIONS

Incidence in Controlled Trials With Bupropion:

Adverse Events Associated

With Discontinuation of Treatment Among Patients Treated With Bupropion Hydrochloride Extended-Release Tablets (SR):
Table 4. Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials
  Adverse Event Term Bupropion 300 mg/day (n = 376)

Bupropion 400 mg/day (n = 114)

Placebo (n = 385)
  Rash   Nausea   Agitation   Migraine



2.4% 0.8% 0.3% 0.0%



0.9% 1.8% 1.8% 1.8%



0.0% 0.3% 0.3% 0.3%



Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With Bupropion Hydrochloride Extended-Release Tablets (SR):




WARNINGSPRECAUTIONS
Table 5. Treatment-Emergent Adverse Events in Placebo-Controlled Trials Adverse events that occurred in at least 1% of patients treated with either 300 or 400 mg/day of bupropion hydrochloride extended-release tablets (SR), but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder.
 Body System/Adverse Event Bupropion 300 mg/day (n = 376)

Bupropion 400 mg/day (n = 114)

Placebo (n = 385)
 Body (General)     Headache     Infection     Abdominal pain     Asthenia     Chest pain     Pain     Fever







  26% 8% 3% 2% 3% 2% 1%







  25% 9% 9% 4% 4% 3% 2%







  23% 6% 2% 2% 1% 2%






denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
 Cardiovascular     Palpitation     Flushing     Migraine     Hot flashes




  2% 1% 1% 1%




  6% 4% 4% 3%




  2% 1% 1%

denotes adverse events occurring in greater than 0 but less than 0.5% of patients.


 Digestive     Dry mouth     Nausea     Constipation     Diarrhea     Anorexia     Vomiting     Dysphagia







  17% 13% 10% 5% 5% 4% 0%







  24% 18% 5% 7% 3% 2% 2%







  7% 8% 7% 6% 2% 2% 0%







 Musculoskeletal     Myalgia     Arthralgia     Arthritis     Twitch




  2% 1% 0% 1%




  6% 4% 2% 2%




  3% 1% 0%



denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
 Nervous system     Insomnia     Dizziness     Agitation     Anxiety     Tremor     Nervousness     Somnolence     Irritability     Memory decreased     Paresthesia     Central nervous system stimulation











  11% 7% 3% 5% 6% 5% 2% 3% 1% 2%








denotes adverse events occurring in greater than 0 but less than 0.5% of patients.


  16% 11% 9% 6% 3% 3% 3% 2% 3% 2% 1%











  6% 5% 2% 3% 1% 3% 2% 2% 1% 1% 1%











 Respiratory     Pharyngitis     Sinusitis     Increased cough



  3% 3% 1%



  11% 1% 2%



  2% 2% 1%



 Skin     Sweating     Rash     Pruritus     Urticaria




  6% 5% 2% 2%




  5% 4% 4% 1%




  2% 1% 2% 0%




 Special senses     Tinnitus     Taste perversion     Blurred vision or diplopia



  6% 2% 3%



  6% 4% 2%



  2% 2%

denotes adverse events occurring in greater than 0 but less than 0.5% of patients.

 Urogenital     Urinary frequency     Urinary urgency     Vaginal hemorrhage     Urinary tract infection


Incidence based on the number of female patients.

  2% 0% 1%

denotes adverse events occurring in greater than 0 but less than 0.5% of patients.


  5% 2% 2% 0%




  2% 0%


denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials:
Bupropion 300 mg/day:

Bupropion 400 mg/day:

Other Events Observed During the Clinical Development and Postmarketing
Experience of Bupropion:

WARNINGSPRECAUTIONS





Body (General): PRECAUTIONS

Cardiovascular:
PRECAUTIONS

Digestive:

Endocrine:

Hemic and Lymphatic:

Metabolic and Nutritional:

Musculoskeletal:

Nervous System:

Respiratory:

Skin:

Special Senses:

Urogenital:

DRUG ABUSE AND DEPENDENCE


Controlled Substance Class:
Humans:






Animals:

OVERDOSAGE


Human Overdose Experience:


Overdosage Management:






Physicians’ Desk Reference

BUPROPION HYDROCHLORIDE DOSAGE AND ADMINISTRATION


General Dosing Considerations:WARNINGS


Initial Treatment:

Increasing the Dosage Above 300 mg/day:

Maintenance Treatment:
CLINICAL TRIALSCLINICAL PHARMACOLOGY
Dosage Adjustment for Patients with Impaired Hepatic Function:
CLINICAL PHARMACOLOGYWARNINGSPRECAUTIONS
Dosage Adjustment for Patients with Impaired Renal Function:
CLINICAL PHARMACOLOGYPRECAUTIONS
#®

MEDICATION GUIDE


Bupropion Hydrochloride Extended-Release Tablets, USP (SR)



IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section isentitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?” 

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Talk to your, or your family member’s, healthcare provider about:
  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:






What else do I need to know about antidepressant medicines?
  • Stopping an antidepressant medicine suddenly can cause other symptoms. Never stop an antidepressant medicine without first talking to a healthcare provider.
  • It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressants are medicines used to treat depression and other illnesses.
  • Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines have other side effects.
  • Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Antidepressant medicines can interact with other medicines.
  • Talk to your child’s healthcare provider for more information. Not all antidepressant medicines prescribed for children are FDA approved for use in children.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking.

Although bupropion hydrochloride extended-release tablet (SR) is not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN which is used to help patients quit smoking. ®*

Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.














What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)? 


Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (SR), especially in people:
  • with certain medical problems.
  • who take certain medicines.
Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (SR) unless your doctor has said it is okay to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (SR), stop taking the tablets and call your doctor right away.
  • The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking. High blood pressure (hypertension). Some people get high blood pressure, that can be severe, while taking bupropion hydrochloride extended-release tablets (SR).
  • if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. Severe allergic reactions. Some people have severe allergic reaction to bupropion hydrochloride extended-release tablets (SR). Stop taking bupropion hydrochloride extended-release tablets (SR) and call your doctor right away
  • Some patients have unusual thoughts or behaviors while taking bupropion hydrochloride extended-release tablets (SR), including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your doctor. Unusual thoughts or behaviors.
What is bupropion hydrochloride extended-release tablet (SR)?



Who should not take bupropion hydrochloride extended-release tablets (SR)?
Do not take bupropion hydrochloride extended-release tablets (SR) if you
  • have or had a seizure disorder or epilepsy.
  • Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (SR). are taking ZYBAN (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN Tablets or WELLBUTRIN XL Extended-Release Tablets. ®* ®* ®*
  • drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
  • have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL (phenelzine sulfate), PARNATE (tranylcypromine sulfate), or MARPLAN (isocarboxazid). ®* ®* ®*
  • have or had an eating disorder such as anorexia nervosa or bulimia.
  • are allergic to the active ingredient in bupropion hydrochloride extended-release tablets (SR), bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in bupropion hydrochloride extended-release tablets (SR).
What should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?


a.    Tell your doctor about your other medical conditions including if you:
  • It is not known if bupropion hydrochloride extended-release tablets (SR) can harm your unborn baby. are pregnant or plan to become pregnant.
  • Bupropion passes through your milk. It is not known if bupropion hydrochloride extended-release tablets (SR) can harm your baby. are breastfeeding.
  • especially cirrhosis of the liver. have liver problems,
  • have kidney problems.
  • have an eating disorder such as anorexia nervosa or bulimia.
  • have had a head injury.
  • have had a seizure (convulsion, fit).
  • have a tumor in your nervous system (brain or spine).
  • have had a heart attack, heart problems, or high blood pressure.
  • are a diabetic taking insulin or other medicines to control your blood sugar.
  • drink a lot of alcohol.
  • abuse prescription medicines or street drugs.
Tell your doctor about all the medicines you take,

How should I take bupropion hydrochloride extended-release tablets (SR)?
  • Take bupropion hydrochloride extended-release tablets (SR) exactly as prescribed by your doctor.
  • You must swallow the tablets whole. Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (SR). Tell your doctor if you cannot swallow medicine tablets.
  • Take bupropion hydrochloride extended-release tablets (SR) at the same time each day.
  • Take your doses of bupropion hydrochloride extended-release tablets (SR) at least 8 hours apart.
  • You may take bupropion hydrochloride extended-release tablets (SR) with or without food.
  • If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. Too much bupropion hydrochloride extended-release tablets (SR) can increase your chance of having a seizure. This is very important.
  • If you take too much bupropion hydrochloride extended-release tablets (SR), or overdose, call your local emergency room or poison control center right away.
  • Do not take any other medicines while using bupropion hydrochloride extended-release tablets (SR) unless your doctor has told you it is okay.
  • It may take several weeks for you to feel that bupropion hydrochloride extended-release tablet (SR) is working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (SR) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablet (SR) is working for you.
  • Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (SR) without talking with your doctor first.



What should I avoid while taking bupropion hydrochloride extended-release tablets (SR)?
  • Do not drink a lot of alcohol while taking bupropion hydrochloride extended-release tablets (SR). If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
  • Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablet (SR) affects you. Bupropion hydrochloride extended-release tablets (SR) can impair your ability to perform these tasks.

What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?









Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store bupropion hydrochloride extended-release tablets (SR)?
  • Store bupropion hydrochloride extended-release tablets (SR) at room temperature. Store out of direct sunlight. Keep bupropion hydrochloride extended-release tablets (SR) in its tightly closed bottle.
  • Bupropion hydrochloride extended-release tablets (SR) may have an odor.
General information about bupropion hydrochloride extended-release tablets (SR).





What are the ingredients in bupropion hydrochloride extended-release tablets (SR)?





®®®®®®Rx only



Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202
Caraco Pharmaceutical Laboratories, Ltd.

Manufactured at: Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Sun Pharmaceutical Ind. Ltd.

ISS. 04/2010 PJPI0292

BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE

Bupropion hydrochloride

Bupropion hydrochloride

Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50436-9102(NDC:47335-737)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE BUPROPION 150 mg

Inactive Ingredients

Ingredient Name Strength
hydroxypropyl cellulose
SACCHARIN
ANHYDROUS LACTOSE
SILICON DIOXIDE
talc
STEARIC ACID
POLYVINYL ALCOHOL
titanium dioxide
POLYETHYLENE GLYCOL 3350

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 9 mm 737 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-9102-1 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078866 2010-04-08


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